ENDFLU | Evaluation of ratioNally Designed Influenza vaccines

Summary
ENDFLU will develop three complementary next-generation influenza vaccination strategies for the world, fueled by the unique combined expertise of Indian and European partners in rational vaccine design and development:
• Create a repository of pre-pandemic GMP-compliant MVA-based vaccine seeds, each encoding an influenza hemagglutinin (HA), based on European partners demonstration of clinical safety and cross-clade immunogenicity of MVA-H5.
• Optimize and select protein- and MVA-based constructs developed by Indian and European ENDFLU partners, resulting in a rationally combined vaccine formulation that induces broadly protective humoral and cell-mediated immunity against all influenza manifestations. This will be advanced in a Phase I clinical trial and Controlled Human Infection Model (CHIM) study.
• Pre-clinically advance other promising protein- and MVA-based constructs toward future development beyond ENDFLU.
Constructs to elicit humoral immunity build on rationally-designed and optimized conserved epitopes of influenza surface proteins, HA stem- and HA head-nanoparticles, and NA-M2e fusions either as proteins or MVA expressed. Other MVA-based constructs to elicit cell-mediated immunity will encode conserved internal protein T cell epitopes, as an artificial polyepitope. The best candidates will be selected based on biochemical, biophysical, functional and manufacturing criteria, and immunogenicity and protective efficacy in mice and ferrets. The selected protein-based construct will enter a Part A Phase I clinical trial in India assessing safety, immunogenicity and optimal dose, to be combined with the selected MVA-based construct. This protein-MVA combination will enter a Part B Phase I clinical trial in the EU, assessing safety and immunogenicity, followed by the CHIM study. A dissemination and exploitation plan, and collaboration with key scientific advocacy organizations will facilitate the adoption of ENDFLU achievements to combat influenza worldwide.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/874650
Start date: 01-08-2020
End date: 31-07-2025
Total budget - Public funding: 14 444 867,00 Euro - 8 646 254,00 Euro
Cordis data

Original description

ENDFLU will develop three complementary next-generation influenza vaccination strategies for the world, fueled by the unique combined expertise of Indian and European partners in rational vaccine design and development:
• Create a repository of pre-pandemic GMP-compliant MVA-based vaccine seeds, each encoding an influenza hemagglutinin (HA), based on European partners demonstration of clinical safety and cross-clade immunogenicity of MVA-H5.
• Optimize and select protein- and MVA-based constructs developed by Indian and European ENDFLU partners, resulting in a rationally combined vaccine formulation that induces broadly protective humoral and cell-mediated immunity against all influenza manifestations. This will be advanced in a Phase I clinical trial and Controlled Human Infection Model (CHIM) study.
• Pre-clinically advance other promising protein- and MVA-based constructs toward future development beyond ENDFLU.
Constructs to elicit humoral immunity build on rationally-designed and optimized conserved epitopes of influenza surface proteins, HA stem- and HA head-nanoparticles, and NA-M2e fusions either as proteins or MVA expressed. Other MVA-based constructs to elicit cell-mediated immunity will encode conserved internal protein T cell epitopes, as an artificial polyepitope. The best candidates will be selected based on biochemical, biophysical, functional and manufacturing criteria, and immunogenicity and protective efficacy in mice and ferrets. The selected protein-based construct will enter a Part A Phase I clinical trial in India assessing safety, immunogenicity and optimal dose, to be combined with the selected MVA-based construct. This protein-MVA combination will enter a Part B Phase I clinical trial in the EU, assessing safety and immunogenicity, followed by the CHIM study. A dissemination and exploitation plan, and collaboration with key scientific advocacy organizations will facilitate the adoption of ENDFLU achievements to combat influenza worldwide.

Status

SIGNED

Call topic

SC1-BHC-32-2019

Update Date

26-10-2022
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Horizon 2020
H2020-EU.3. SOCIETAL CHALLENGES
H2020-EU.3.1. SOCIETAL CHALLENGES - Health, demographic change and well-being
H2020-EU.3.1.2. Preventing disease
H2020-SC1-2019-Single-Stage-RTD
SC1-BHC-32-2019 Towards a next generation influenza vaccine to protect citizens worldwide – an EU-India collaboration